are correctly summarized and that any statistical analyses are accurately described.

Project Managers: Coordinate the report preparation process, ensuring that the timeline for report completion and submission is met and that all stakeholders are involved in the review process.

Quality Assurance (QA): Review the report to ensure compliance with GLP guidelines and internal quality standards. Ensure that the report is complete, accurate, and ready for submission.

Regulatory Affairs Personnel: Ensure that the report meets regulatory requirements for submission to authorities, including any additional information that may be required for regulatory compliance.

4) Procedure

The following steps outline the procedure for preparing and submitting animal study reports:

1. Step 1: Data Collection and Finalization
   1. Ensure that all data from the animal study are finalized and available for inclusion in the report. This includes raw data, analysis results, and any supplementary materials such as images, graphs, or charts.
   2. Review the study protocol and ensure that all study objectives, methodologies, and data collection points are accurately represented in the final dataset.
2. Step 2: Report Preparation
   1. Begin by compiling the study data and ensuring that all relevant sections of the report are completed, including an introduction, study objectives, methodology, results, discussion, and conclusions.
   2. Ensure that the report is written in a clear, concise, and objective manner, presenting the findings of the study in a logical format. The report should be easy to understand and scientifically accurate.
   3. Ensure that all relevant sections are included, such as the study design, dosing regimen, control groups, animal species used, sample sizes, and statistical methods employed.
   4. Document any deviations from the protocol and explain the reasons for these deviations and their impact on the study results.
3. Step 3: Data Analysis and Interpretation
   1. Perform statistical analyses on the study data and ensure that the results are properly interpreted. This includes analyzing trends, differences between treatment groups, and other relevant outcomes.
   2. Ensure that the statistical methods used are appropriate for the data type and study design, and that the results are clearly presented in the report with relevant statistical details (e.g., p-values, confidence intervals, effect sizes).
   3. Interpret the data in the context of the study’s objectives, highlighting key findings and their relevance to the study hypotheses.
4. Step 4: Review and Quality Control
   1. Ensure that the report is reviewed by all relevant stakeholders, including study directors, data analysts, QA personnel, and regulatory affairs staff. The review process should check for data accuracy, clarity, completeness, and compliance with protocols.
   2. QA personnel should conduct an audit of the report to ensure that it complies with GLP and other applicable regulatory standards.
   3. Ensure that all figures, tables, and graphs are correctly labeled, and that all data are presented in a manner consistent with the report’s objectives and conclusions.
5. Step 5: Report Approval
   1. Once the report is reviewed and any necessary revisions are made, submit the report for final approval by the study director and any other relevant stakeholders.
   2. The study director or project manager should ensure that the report meets all regulatory requirements and internal quality standards before approval for submission.
6. Step 6: Report Submission
   1. Prepare the final version of the report for submission to regulatory authorities or other stakeholders. Ensure that the report is formatted according to submission guidelines, including any required cover letters or additional documentation.
   2. Ensure that all relevant documents, such as study protocols, raw data, and quality control logs, are included as part of the submission package.
   3. Submit the report to the appropriate regulatory authorities or other stakeholders within the required timeframe.
7. Step 7: Archiving of Reports
   1. Ensure that the final report and all associated documentation are archived according to internal policies and regulatory requirements. This includes both physical and electronic records.
   2. Ensure that the reports are stored securely, with appropriate backup and access controls to protect the integrity and confidentiality of the data.
8. Step 8: Sample Disposal
   1. Ensure that all biological samples, chemicals, and laboratory waste generated during the study are disposed of in accordance with biosafety and waste disposal regulations.
   2. Ensure that hazardous materials are disposed of in designated biohazard or chemical waste containers to minimize environmental impact.

5) Documents

The following documents should be maintained during the preparation and submission of animal study reports:

1. Study Protocols
2. Raw Data Logs
3. Statistical Analysis Results
4. Draft and Final Study Reports
5. Audit and Review Records
6. Submission Documents
7. Sample Disposal Records

6) Abbreviations

• GLP: Good Laboratory Practices
• FDA: Food and Drug Administration
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• IND: Investigational New Drug

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• OECD Guidelines for Good Laboratory Practice (GLP)
• FDA Guidelines for Preclinical Safety Testing
• ICH E6 Good Clinical Practice Guidelines
• International Standards for Report Preparation and Submission

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Animal Study Report Template

Study ID	Study Title	Study Director	Submission Date	Regulatory Authority